"The mainstream supplements industry can make a valuable contribution to public health."

Related tags:
FDA, Supplements, DSHEA

Acute non-viral hepatitis is tragic, whether it’s potentially linked to a product labeled as a dietary supplement or not. It is also tragic when critics of supplements use it as a stick to beat the entire industry with, despite there being many unanswered questions.

Before I begin, I want to stress that I do not want to trivialize the harm that has been endured by the people in Hawaii recently. We’re talking about 29 cases of liver damage, 11 of which led to hospitalizations, two liver transplants, and one death. This is tragic and our thoughts are with those people and their families.

But in an article entitled ‘Liver or let die’
from the American Council on Science and Health (ACSH) the cases are used as an opportunity to bash all supplements, and spread a little misinformation.

The ACSH starts with: “In the never-ending battle between the unregulated multibillion dollar supplements industry and legitimate medicine, this shady industry is trying to recover from a pretty good licking it received today from the FDA.”

I read a lot of what the ACSH puts out, and for an organization that claims to deal in ‘Science. Not hype’, there’s a familiar factual inaccuracy about the supplement industry eight words into that first sentence.

That untruth (that supplements are unregulated) is not perpetuated, however, with Dr. Josh Bloom, ACSH’s Director of Chemical and Pharmaceutical Sciences, stating: “When companies sell unapproved drugs under the guise of ‘supplements’ (which, because of a sleazy law pushed through Congress by Utah’s Sen. Orrin Hatch in 1994, are exempt from FDA approval) and they start killing people, the real mystery is how companies are allowed to sell this garbage, and why more people haven’t been killed.”

Dr Bloom, who was previously an employee of Wyeth and Pfizer and is described as “a long-time critic of the supplement industry”, at least notes that there are regulations pertaining to dietary supplements.

Unanswered questions

There’s also an error at the end of the first sentence – the FDA has not given the industry a ‘good licking’. The Agency is investigating liver damage cases potentially linked to one product, which is labeled as OxyElite Pro
. USPLabs, the company behind OxyElite Pro, has not had an easy ride from us in the past relating to use of the controversial ingredient DMAA, but, in response to the reports from Hawaii, the company has reacted responsibly: It has removed the products in question from distribution, and said it is cooperating with FDA. Let’s be clear, nothing has been established yet in Hawaii and we need to give the investigators time to investigate.

With the products no longer available, there is time to address several unanswered questions:
Are the products used by the unfortunate victims, which are labeled as OxyElite Pro, the cause of the liver damage? With 24 out of 29 cases of liver damage allegedly sharing the product labeled as OxyElite Pro as a common link you have to say it's highly suggestive but not definitive.
Another question is if the product labeled as OxyElite Pro is actually OxyElite Pro, considering that counterfeit products are claimed to be on the market? Counterfeiting is a problem for many industries, from foods to pharmaceuticals. Finally, this product is sold nationwide and has been on the market for a while, so why now and why only Hawaii? The CDC is reportedly investigating other cases of liver injury nationwide that may be related... may be related but nothing is confirmed at this stage.

Let’s wait for all the evidence before we pass judgment.

‘A splendid job’

Leaving that as it is, let’s go back to the ACSH article and the beating up on supplements in general. Here’s Dr Bloom’s closing gambit: “These supplement companies have done an absolutely splendid job of portraying themselves as the little guys — knights in shining armor that provide an alternative to those deadly drugs from the pharmaceutical industry. The problem is that this is utterly false. The supplement industry is enormous and takes advantage of America’s scientific naivety in an insidious, but highly effective way.”

Allow me to flip this and argue that members of the traditional pill-for-every-ill medical community have done an absolutely splendid job of portraying supplements as unregulated, ineffective, and perhaps even dangerous.

I do agree that the supplement industry is enormous – the numbers speak for themselves. It’s also growing, and there are reasons for that. Another truth: Several pharmaceutical companies have significant interests in the dietary supplements, including Dr Bloom’s former employer.

If everyone ate well and exercised regularly, then you could imagine a health utopia where supplements are not needed (Let food be thy medicine). Continue that train of thought, and you could also imagine that pharmaceuticals would probably be in much lower demand. But while the medical community is focused on treating people (let our medicine be thy medicine!) and not about working harder to educate the public on the benefits of good diet and lifestyle then we won’t get there. People do have nutrient gaps, and supplements are there to supplement the diet.

The issue is not the regulations. The issue is enforcement, and this publication supports the increase in enforcement from FDA over recent years.

It’s all about safety & efficacy
. Unsafe or bogus products have no place in the dietary supplements industry, but there is most definitely a place for the dietary supplements industry.

Stephen Daniells is the Senior Editor of NutraIngredients-USA & FoodNavigator-USA. He has a PhD in chemistry from the Queen's University of Belfast in Northern Ireland. He has been writing about the food and dietary supplement industries in the US and Europe for eight years.

This content is copyright protected

However, if you would like to share the information in this article, you may use the headline, summary and link below:

Acute non-viral hepatitis is tragic, whether it’s potentially linked to a product labeled as a dietary supplement or not. It is also tragic when critics of supplements use it as a stick to beat the entire industry with, despite there being many unanswered questions.

7 comments(Comments are now closed)

Bif Pharma Drugs are more dangerous....with limited testing

Buy certified organic supplements, foods and superfoods and you eliminate the frauds.

Report abuse

Posted by CC05 December 2013 | 13h382013-12-05T13:38:45Z

Responding to the herbal products study

Josh,
We published an article about that study on Monday: http://www.nutraingredients-usa.com/Research/Contamination-substitution-present-in-many-herbal-products-but-is-DNA-barcoding-of-herbals-fit-for-purpose
The opinion of the analytical expert I spoke to, and the expert who subsequently commented on the article, is that there are a lot of questions about DNA barcoding in its current form. Any and all attempts to improve the quality of supplements should be welcomed, which is why I covered that particular study, but there are questions about applying that particular analytical technique at this time.

According to the good manufacturing practices for dietary supplements, companies must ensure that products match label claims for the contents. We've already seen warning letters related to that. It's about enforcement from FDA and compliance by the companies, not a lack of regulation.

My whole point throughout this has not been to say that the supplements industry is perfect. Only the most zealous supporter could even think that. There are bad apples in every industry. My comment was about cherry picking the bad press to bash all supplements. Good nutrition, and I include supplements in there, can go a long way to improving quality of life.

Report abuse

Posted by Stephen Daniells16 October 2013 | 18h472013-10-16T18:47:21Z

Comment on new supplement study.

Hi Stephen-
I was wondering if you could comment on a newly released study which shows that nearly 60 per cent of the herbal products contained plant species not listed on the label? http://www.medicalnewstoday.com/releases/267363.php

Report abuse

Posted by Josh Bloom16 October 2013 | 18h112013-10-16T18:11:40Z

the elephant in the corner

Its amazing that the supplement industry AEs and even fatalities don't even begin to compare with the 100,000 + deaths caused by properly prescribed pharmaceuticals. I don't have enough space here to list the recalled drugs like Vioxx that have killed and damaged people lives in numbers that make this OxyElite liver case relatively insignificant. The real sleazy mystery is how the pseudo science of big Pharma gets approval from the FDA and then we see recalls and side effects, which are all calculated business risks in the name of profit. The supplement industry would not be growing so quickly if our US healthcare system was effective.. and not a profit based disease-care system. The data was published in 2000 in JAMA, in black and white, open your eyes folks!

Report abuse

Posted by Marco 15 October 2013 | 19h302013-10-15T19:30:38Z

NDI, GRAS & safety

Dr Bloom -
Thank you for posting a reply. Under the New Dietary Ingredient (NDI) section of the Federal Food, Drug, and Cosmetic Act, there is a requirement to notify the FDA “at least 75 days before being introduced or delivered for introduction into interstate commerce” that the dietary ingredient will reasonably be expected to be safe (section 413 of the FD&C Act, 21 U.S.C. 350b). The Agency reacted to DMAA by claiming it was not an old dietary ingredient (ie. on the market prior to 1994) and therefore needed an NDI. Since no NDI had ever been submitted, products containing the ingredient are considered adulterated. Hence the warning letters. I think it’s improbable the agency would have approved an NDI if one was submitted, and people knew it, and so the ingredient is effectively removed from the market. If the regulations had been sufficiently enforced earlier then perhaps DMAA would not have established the footprint on the market that it did.
Dr Dan Fabricant at the FDA has said numerous times that he considers the number of NDIs submitted over the years to be insufficient considering the number of products on the market. I fully expect the Agency to focus more attention, and send more warning letters, on this issue over the next few years.
On a different point, there also seems to be differing views of supplements – There appears to be a mindset among some people that it is a choice between supplements or pharmaceuticals, but they are not the same thing, nor should anyone think that they have the same purpose. Supplements should be considered a part of the diet, and companies should strive to ensure they are compliant with the law.
Another point to consider is that, under the terms of the Generally Recognized as Safe (GRAS) system, many ingredients are available to foods and beverages with no pre-market safety verification from the FDA. Self-affirmation of the GRAS status is up to the company and a third party.

Report abuse

Posted by Stephen Daniells11 October 2013 | 00h262013-10-11T00:26:03Z

Well balanced and covering the bases

Brilliantly written. Refreshing to read a balanced reporting of a product that should be investigated and is not really a reflection of an entire industry.

Report abuse

Posted by C.M. Roesch10 October 2013 | 22h292013-10-10T22:29:05Z

Response from J. Bloom

Stephen-
Many of your points are valid. Yes- counterfeit drugs are a world-wide problem. And this may be an isolated incident. And Wyeth (now Pfizer) has gotten into the supplement business (and my criticism holds true for them as well). But where we differ is on the role of the FDA in all of this. Yes- they have highlighted certain drugs for increased scrutiny, but this is *after* problems have been found. Since they have no say in what is marketed in the first place, they can only act retroactively. Which begs the question, "How did these bad actors get into stores in the first place?" The answer: because a ludicrous law enabled vitamin stores to sell anabolic steroids, dangerous stimulants such as DMAA and ephedra, colloidal silver—things that would never get past the FDA approval process. Furthermore, there is little doubt that your industry pushes the "organic" and "natural" concepts (and very successfully so) to consumers who mistakenly believe that natural equals safe (keep in mind that some of the most potent toxins on earth come from natural sources) and that the origin of a substance has anything whatsoever with its properties—both entirely false. Whatever you think about prescription pharmaceutical (and they are far from perfect), they are at least tested for safety on non-human subjects.

Technical / white paper

18-Feb-2015 - Gone are the days when the Brand Owner or Own Label Distributor could abdicate the responsibility for the quality of their products to the Contract Manufacturing Organization. This is exactly why Gemini Pharmaceuticals
developed a Quality Partnership Program. With over...

Technical / white paper

01-Mar-2015 - InterHealth offers weight-loss ingredient brands backed by published clinical research and extensive quality testing per GLP guidelines. We know that your priority is selecting the finest weight loss ingredients on the market for your customers. You need a partner who...

Technical / white paper

16-Feb-2015 - Half of US consumers surveyed say the fiber level of a food product influences their purchase decision. This is especially true for younger people. The majority of consumers surveyed were interested in healthy, sugar-reduced food applications.

Technical / white paper

03-Feb-2015 - InterHealth’s weight-loss ingredients—Meratrim®, Super CitriMax®, 7-Keto® and LOWAT®—are backed by weight management clinical research. Thinking about formulating a non-stimulant based product? How about an appetite suppressor or an adiponectin regulator? We will collaborate with you determine which one of our...

Data sheet

22-Jan-2015 - Slimaluma is the only Caralluma Fimbriata extract clinically proven to support healthy weight management. This patented, standardized extract has a dual mechanism of action: (1) appetite suppression and (2) abdominal fat reduction. Several studies have been conducted on Slimaluma, including...

Technical / white paper

19-Jan-2015 - Scientists now understand that high-calorie, processed foods contribute to impaired glucose tolerance, which affects blood glucose metabolism, and may lie at the heart of the growing overweight population. Emerging science shows the promise of Salacia oblonga, a traditionally used herbal...

Clinical study

01-Feb-2014 - In the double-blind study, 123 participants were randomly selected to take IQP-PV-101, (Phase 2® white kidney bean extract) or a placebo. Participants taking Phase 2 lost an average of 7 pounds at the conclusion of 12 weeks and lost significantly more body...

Clinical study

01-Mar-2015 - ProHydrolase is a bio-sufficient supplement designed to build muscle mass and accelerate muscle recovery when used as an ingredient in protein supplements or meal replacements. This clinically studied enzyme blend digests protein into bio-usable form, taking full advantage of the...

Technical / white paper

30-Jan-2015 - With the uptrend in protein-packed applications and increasing allergen awareness, meat protein can be a desirable alternative to plant- and dairy-based proteins. This white paper compares meat proteins – specifically, concentrated chicken protein – to other common proteins, and outlines...